510(k) · Cleared
ClearedPrimagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model PG4-7061,-7071,-7081, PG4-7062, 7072-70
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primed Medical Products, Inc. · FXX Mask, Surgical
Cleared on Sep 25, 2009 as substantially equivalent to K081633 (Primed Medical Products, Inc., 2008) after an 81-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Sep 25, 2009
- Review
- 81 days
- Class
- Class II
- Product code
- FXX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001951 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK001951 Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated…Primeline Medical Products, Inc. · 2000
- 1 generation backK081633 Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksPrimed Medical Products, Inc. · 2008
- This deviceK092012 Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium…Primed Medical Products, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001951 | Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop… | Primeline Medical Products, Inc. | 2000 | — |
| −1 | K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks | Primed Medical Products, Inc. | 2008 | — |
| 0 (this device) | K092012 | Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large)… | Primed Medical Products, Inc. | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FXX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FXX device
- #1 K201479 DemeMASKscore 40.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081633 | Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksSummary page 1…ame: Surgical Mask Classification Name: Surgical Mask, 878.4040; Product code FXX Predicate Device: .Surgical Mask 510O(k) #K081633 Description of the Device: These surgical masks are deltoid shape, waterfall-pleated devices manufactured from selected :non-w… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K081633.
How does its category compare?
All FXX devicesFXX Mask, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FXX
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FXX
123in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FXX
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FXX
11in 2025
MAUDE reports naming product code FXX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 7 | 144 | 0 | 9 |
| 2011 | 6 | 137 | 0 | 8 |
| 2012 | 1 | — | 0 | 22 |
| 2013 | 3 | 219 | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 5 | 298 | 0 | 14 |
| 2016 | 5 | 268 | 0 | 16 |
| 2017 | 1 | — | 0 | 45 |
| 2018 | 3 | 119 | 0 | 21 |
| 2019 | 4 | 124 | 2 | 23 |
| 2020 | 27 | 113 | 0 | 60 |
| 2021 | 218 | 162 | 0 | 67 |
| 2022 | 91 | 113 | 0 | 21 |
| 2023 | 22 | 139 | 1 | 21 |
| 2024 | 15 | 263 | 2 | 21 |
| 2025 | 6 | 123 | 0 | 11 |
| 2026 | 5 | 142 | 0 | — |
What is it indicated for?
PRIMAGARD Delta Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K092012: Primagard Delta Fit 80,120, 160 Surgical Face Mask (Small, Medium, Large) Model PG4-7061,-7071,-7081, PG4-7062, 7072-70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K092012
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026